Comprehensive Versus Traditional Lifestyle Program

Obesity Clinical Trial

Official title:

THINK (Translational Health in Nutrition and Kinesiology) Junior Edition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182621
• Other study ID #: 20120486
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: June 7, 2017
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.

Description:

Despite recommendations that school-based interventions use a comprehensive approaches for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years old) following a 10week intervention period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• To be eligible for this study, subjects had to be between the ages of eight and 12, enrolled in a YMCA program, and able to participate in physical activity. Parents were provided with information packets regarding project details, a parental consent form, and a child assent form. Once the subjects assented and parents consented, a health questionnaire regarding child's age, gender, race/ethnicity, health history and SES was completed.

Exclusion Criteria:

• Subjects with metabolic, cardiovascular, neuromuscular and psychological disorders and with medications that would interfere with testing results were excluded from the study.

Related Conditions & MeSH terms

• Cognitive Function 1, Social
• Obesity
• Physical Fitness

Intervention

Behavioral:
• THINK
The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.
• SPARK
traditional YMCA program

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	University of Tennessee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aerobic Fitness	The National Institute of Medicine Toolbox two-minute Walk Endurance Test was used to measure aerobic fitness	Baseline and 10 Weeks
Primary	Change in Grip Strength	Grip strength was measures using a Jamar plus handgrip dynamometer.	Baseline and 10 Weeks
Primary	Change in Abdominal Strength	The one-minute curl-up test was used to measure abdominal strength and endurance.	Baseline and 10 Weeks
Primary	Change in Lower Body Strength	Lower body strength, specifically for the quadriceps muscle group, was assessed with the wall squat test. A vertical jump test utilizing a Vertec. was used to assess lower body power . The vertical jump test data were used to estimate average power (W) according to the Lewis formula Average Power (W) = v4.9 x mass (kg) x vVJ (m) x 9.81.	Baseline and 10 Weeks
Primary	Change in Percent Body Fat	Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer.	Baseline and 10 Weeks
Primary	Change in BMIz	A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender.	Baseline and 10 Weeks
Primary	Change in Visceral Abdominal Fat	The Saggital Abdominal Height was used as estimate of visceral abdominal fat using a portable anthropometer.	Baseline and 10 Weeks
Primary	Change in Waist circumference	Waist circumference was used to measure central adiposity with a Gulick body tape measure.	Baseline and 10 Weeks